1. The Field of the Invention
The present invention is in the field of prophylactic sheaths for protecting or shielding medical needles. Particularly, the present invention relates to prophylactic sheaths for protecting or shielding medical needles during handling, storage, use, reuse and disposal of medical needles.
2. Relevant Technology
Needles, such as those used in the medical arts, are typically equipped with a removable prophylactic sheath to protect the needle from damage, to keep the needle sterile during storage and to prevent accidental puncture of the user. Although traditional prophylactic sheaths may adequately protect the needle from damage, keep the needle sterile and prevent accidental puncture before use, there has been a problem with accidental needle punctures after use, especially during reinsertion of the needle into the prophylactic sheath.
While it may hurt to miss the prophylactic sheath and puncture one's self with a sterile needle, it typically has no long lasting consequences. It can, however, be a different story if the handler has previously used the medical needle to inject or extract fluids from a patient. For example, a medical provider is often not aware whether a patient is carrying a communicable disease. With the increasing prevalence of communicable diseases, such as hepatitis and AIDS, medical providers must assume that every patient has a communicable disease. Hence, an accidental needle puncture with a medical needle that has been used to extract fluid from, or inject fluid into, a patient is a serious concern that could even be a matter of life or death.
Traditional sheaths used to package medical needles prior to use, as illustrated in FIG. 1A and 1B, typically comprise a thin tube 12 manufactured from flexible plastic having relatively small openings at both of ends 14 and 16. Any type of medical needle can be inserted into either end of the packaging sheath 12, including winged needles 120 having wing portions 122 as depicted in FIGS. 1A and 1B. The sheath 12 fits around a hub portion 124 of the needle 120 as a sleeve and engages the medical needle in a press-fit type engagement. The sheath 12 is sized to fit the size of the hub portion 124 and can vary accordingly.
When the medical needle 120 is reinserted back into the packaging sheath 12 after being used, a handler commonly holds the medical needle in one hand and the prophylactic sheath in the other hand. If then, for some reason, such as lack of attention, dim lighting, or an unsteady hand, the handler misgauges the entry of the tip 130 of needle into the opening in sheath 12, the tip 130 of the needle can easily puncture the handler's fingers, hands or other parts of the handler's body. Because of the small target provided by openings 14 and 16, the risk of accidental punctures with contaminated needles is high.
In partial response to the problem of accidental needle punctures, prophylactic sheaths have been provided that include an enlarged conical opening, which provide a larger entry into the prophylactic sheath (not shown). Such sheaths have extending form the conical opening a hollow cylindrical portion similar in design to the sheaths shown in FIGS. 1A and 1B. Such sheaths typically engage the bottom portion of the hub of the medical needle in a press-fit engagement within the end of the hollow cylindrical portion proximal to the conical portion. Although the inclusion of an enlarged opening within prophylactic sheaths may decrease the occurrence of accidental needle punctures, such sheaths have other drawbacks.
One problem is that it is difficult to determine when a needle is securely engaged within the neck region of a prophylactic sheath having an enlarged opening. There is no real indicator that the medical needle has been securely engaged in the prophylactic sheath and, because engagement occurs between the hub and an interior portion of the sheath, it may often be difficult to visually determine if engagement has occurred. Unfortunately, if the needle is not securely engaged within the prophylactic sheath, the needle could fall out of the prophylactic sheath and cause damage or harm to one handling the needle. Moreover, if the diameter of the hub portion 124 differs from needle to needle, a practitioner would have to find a sheath that provided the correct fit, further increasing the risk of improper engagement and risk to the user.
Additionally, typical prophylactic sheaths having an enlarged opening are only adequate in engaging medical needles in a press-fit engagement which have wing portions sized to fit within the conical opening such that the hub portion 124 of the needle may be press fit into the hollow cylindrical portion. As such, medical needles having wing portions which extend so wide that they cannot fit within the conical opening will likely be incapable of forming a press-fit engagement within the cylindrical portion of the sheath. This is because the wings may obstruct entry of the medical needle into the enlarged opening, such that engagement between the hub portion of the needle and the cylindrical portion of the prophylactic sheath is prevented. In other words, the wing portion of the medical needle contacts the outer edge of the enlarged opening, which prevents the hub from reaching the intended point of engagement. This being the case, there are presently no adequate prophylactic sheaths having enlarged openings that can accommodate medical needles having wider wing portions.
In view of the foregoing, it is apparent that there remains a need for a prophylactic sheath having an enlarged opening that is capable of accepting and securely engaging medical needles having a variety of differently-sized wing portions.
In particular, there is a need for a prophylactic sheath having a enlarged opening that is capable of universally accepting medical needles having both narrow-wing portions as well as wide-wing portions in a manner which securely engages either type of needle.
In addition, it would be an advancement in the art to provide a prophylactic sheath which could accommodate and securely engage medical needles having varying-sized hub portions without having to provide a separate sheath for each hub portion size.
It would be a further improvement in the art to provide prophylactic sheaths which provide a definite indicator to the user that the needle inserted therein has been reliably and securely engaged by the sheath.
Such prophylactic sheaths for reliably and securely protecting a variety of differently sized medical needles are disclosed and claimed herein.